Status: Closed
Activation Date: 2007AUG13
Closing Date: 2012MAR08
Phase: I
Description: A Phase I Study Of AZD2281 In Combination With Irinotecan In Patients With Locally Advanced or Metastatic Incurable Colorectal Cancer
Eligibility: Patients with histologically or cytologically documented colorectal cancer and must have locally advanced and/or metastatic colorectal cancer that is considered incurable and suitable for treatment with single agent irinotecan as a palliative intervention by the investigator. No anti-cancer treatment <= 21 days. ECOG 0, 1 or 2. Adequate cardiac function and acceptable end-organ function. No GI tract disease resulting in an iability to adsorb oral medication.
Objective: 1.1 To determine the recommended phase II dose of irinotecan given on day 1 by 90 minute infusion every 21 days with a biologically active dose of AZD2281 given orally bid continuously, in patients with locally advanced or metastatic incurable colorectal cancer. 1.2 To determine the safety, tolerability, toxicity profile, dose limiting toxicities and pharmacokinetic profile of the combination of AZD2281 and irinotecan in this schedule. The correlation, if any, between the toxicity profile and the pharmacokinetics will be determined. 1.3 To assess preliminary evidence of the anti-tumour activity of AZD2281 in combination with irinotecan in patients with colorectal cancer with measurable disease. 1.4 To demonstrate the pharmacodynamic activity of AZD2281 in combination with irinotecan by establishing its effects in tumour biopsies, cheek swabs and blood samples. 1.5 To assess the correlation, if any, between patients with tumours demonstrating microsatellite instability and anti-tu
Participation: Limited to invited centres
Lay Description: The main purpose of this study is to find out what dose of an experimental drug called AZD2281 is safe to give to patients with advanced cancer in combination with another drug called Irinotecan without too many side-effects. Researchers will also look at blood levels to find out how the drug is distributed in the blood and will also investigate epithelial cells, previously removed tumour sample and new tumour biopsies (optional) to see what effects the drug will have on these samples.
Primary Publication Show
Other Publications Show
Inventory
Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I187 | 26 | 14 | 16 | 23 |
(Core size is 0.6 mm)
Hide
Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I187 | 26 | 1 | 2 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I187 | 26 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |